Minn. los pols defienden el proceso del FDA 510 (k)

por Brendon Nafziger, DOTmed News Associate Editor | August 03, 2011
Sen. Franken says
scuttling the 510(k)
process would be
"very harmful."
Both Minnesota's senators and one congressman defended the Food and Drug Administration's 510(k) clearance process from the Institute of Medicine's calls to scrap it, with one senator slamming the IOM's recommendations as "very harmful."

Sens. Amy Klobuchar (D) and Al Franken (D) and Rep. Erik Paulsen (R) issued a joint statement saying they wanted to preserve the so-called fast track clearance process. They also said they supported "targeted reforms" that would cut red tape and speed up getting new devices to market.

"Calling for the elimination of the 510(k) process could be very harmful to innovation," Franken said in a statement. "The report's recommendations would impose new burdens on the medical device industry, without a clear path to a more effective process."
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The politicians are reacting to IOM's long-awaited report, dropped last Friday, which called for eliminating the 510(k) process and re-making it from the ground up. The group found the process was not able to verify the safety or effectiveness of devices, and did not require new products to be innovative.

The 35-year-old 510 (k) process is used to bring to market moderate-risk, Class 2 devices, including most radiological equipment. The FDA received about 4,000 510(k) submissions in 2009, the IOM said.

But Minnesota politicians know their audience. The Midwest state is a medical device hub, home to some of the industry's biggest companies, including Medtronic, Boston Scientific, 3M and St. Jude Medical. About 35,000 Minnesotans are employed by device companies in the state.
(1)

John Heinrich

IOM 510(k) Report

August 04, 2011 01:24

In interpeting these comments, one has to make allowances for Minnesota (the state of my birth) which among other things twice elected a professional wrestler as governor. Al Franken is a moron who probably thinks 510(k) is a new kind of retirement account, put into office by a group of voters with a very peculiar sense of humor. That said, the IOM report is a cause for concern, in large part because it points up the inconsistencies between the intent of the 510(k) legislation and its implementation by the FDA. Whether a completely new process is the solution remains an open issue, but the questions it poses and the recommndations it makes deserve serious consideration.

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(9)

Carole Lamarque

510 (k) process & FDA

August 05, 2011 10:24

I so agree with the 1st commentator, except that
I would not qualify anyone as a "moron", that said, maybe he knows Mr Franken better than I....
I do not quite understand why industries/makers
of medical devices do not work with/in tandem with
the medical-professionals who really shd have a
say in what they need as far as devices for sur-
gery, machineries and films for radiology, come
to mind. Why did the politicians in Minnesota not
offer & support that? Why not talk, discuss this
with experts? why are the "2-worlds" so discon-
nected from one another? I have seen & heard sur-
geons in OR, & OR-RNs tell the surgeon "that is
what we have" and the surgeon' reply "OK we will
have to make do" You do not make do when implan-
ting a device in a human being's body!

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